Home NDC 63433-389 DHC Acne Spot Therapy
Product NDC 63433-389
11-digit product format 634330389
Labeler code 63433
Product ID 63433-389_4ae85fb3-936c-45b4-95d9-b3206952cd94
Type HUMAN OTC DRUG
Nonproprietary name Sulfur
Dosage form CREAM
Route TOPICAL
Labeler DHC USA Incorporated
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-01-01
Substance SULFUR
Active strength 6 mg/.2g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 63433-389-00 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 63433-389-00 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 63433-389-00 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 63433-389-00 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base DHC Acne Spot Therapy
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SULFUR 6 mg/.2g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 70FD1KFU70 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199632 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63433-389-00 DHC Acne Spot Therapy 15 g in 1 TUBE CREAM 15 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63433-389 DHC ACNE SPOT THERAPY (SULFUR) CREAM [DHC USA INCORPORATED] 3 Current NDC, Legacy NDC, 1 package rows 20241018_84d49048-95cf-4f14-9698-c746237fec9d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 19 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Stage Fight Acne Mask SULFUR, RESORCINOL Bioelements, Inc 21ca8de4-28b5-425f-e063-6394a90a3340 2025-12-17 Warnings Exact identifier application number: M006 Spot Defy SULFUR Bioelements, Inc. 6f35f950-8d04-4181-a897-5679fde1e2d9 2025-12-17 Warnings Exact identifier application number: M006 BlemFree SALICYLIC ACID Equibal, Inc. d6720efc-dbbe-4304-bb31-972b506a08bf 2025-12-17 Warnings Exact identifier application number: M006 Blemfree SALICYLIC ACIDE Equibal, Inc. 424dba97-0d40-4801-9fec-4b80ab60f900 2025-12-17 Warnings Exact identifier application number: M006 Renu Laboratories Acne Sulphur L ACNE SULFUR LOTION Renu Laboratories, LLC 13de0e4c-b134-41c0-e054-00144ff88e88 2025-12-16 Warnings Exact identifier application number: M006 SUPER SPOT REMOVER ACNE TREATMENT SALICYLIC ACID ORIGINS NATURAL RESOURCES INC. a0aece76-008b-4af3-be39-13156acc73af 2025-12-15 Warnings Exact identifier application number: M006 DRx Blemish Clarifying Mask SULFUR Dr. Dennis Gross Skincare 7093a8d4-1910-4b23-9d88-d3398db0916a 2025-12-15 Warnings Exact identifier application number: M006 e.l.f. PLZ Clarify Facial Oil SALICYLIC ACID e.l.f. Cosmetics, Inc. 26cde11d-e05e-35a7-e063-6394a90a1fdf 2025-12-14 Warnings Exact identifier application number: M006 Image Clear Cell Acne Spot Treatment SALICYLIC ACID ACNE GEL Swiss-American CDMO, LLC f1b272ba-683e-4eff-a3ac-a046f547d5e5 2025-12-11 Warnings Exact identifier application number: M006 Dr Mellaxeen SKIN SAVER ACNE RELIEF Stick SALICYLIC ACID Longway Lab Inc. 45b85ebb-c00a-61df-e063-6294a90a11bc 2025-12-11 Warnings Exact identifier application number: M006 Dr.Mellaxeen SKIN SAVER DAILY ACNE ESSENTIALS Kit SALICYLIC ACID Longway Technology(Guangzhou)Co.,Ltd. 45b89790-1056-b6a2-e063-6294a90a6f66 2025-12-11 Warnings Exact identifier application number: M006 MULTI-ACTION CLEAR - ACNE CLEARING TREATMENT 2% SALICYLIC ACID SALICYLIC ACID StriVectin Operating Company, Inc. f1d93376-4fc2-751f-e053-2a95a90a6888 2025-12-09 Warnings Exact identifier application number: M006 PowerSpot Cleanse SULFUR Bluemercury 443ae172-bacd-4122-8d78-d2214bcb02fd 2025-12-09 Warnings Exact identifier application number: M006 GM COLLIN PURACNE SALICYLIC ACID Laboratoires Dermo-Cosmetik Inc. 2619cc3b-5246-4519-94c4-07e0338b273c 2025-12-09 Warnings Exact identifier application number: M006 Hero Cosmetics Pimple Correct Salicylic Acid Acne Treatment SALICYLIC ACID Church & Dwight Co., Inc. 869afe67-edae-4778-b990-08c2313d5aad 2025-12-05 Warnings Exact identifier application number: M006 XIMONTH Bee Venom All-In-One Cream SALICYLIC ACID Shantou Ximonth Biotechnology Co., Ltd. 451e2c76-dd85-7b04-e063-6294a90afad3 2025-12-04 Warnings Exact identifier application number: M006 Clear Future Deep Pore Cleanser SALICYLIC ACID Arbonne International, LLC 6f2a66d3-43ec-4bf6-b412-2bcf43f05ab9 2025-12-03 Warnings Exact identifier application number: M006 Clear Future Intensive Spot Treatment SALICYLIC ACID Arbonne International, LLC 84435343-25c7-4aa1-9884-bd0fab2bbccf 2025-12-03 Warnings Exact identifier application number: M006 Adult Acnomel RESORCINOL, SULFUR NUMARK BRANDS, INC 90f80e35-095d-88f9-8ea3-0fd54f1e916c 2025-12-03 Warnings Exact identifier application number: M006 Good Molecules Maximum Strength Acne Gel Cream SALICYLIC ACID Good Molecules, LLC 33dcca56-d5bd-ff7b-e063-6394a90ad51f 2025-12-01 Warnings Exact identifier application number: M006
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63433-389-00 63433038900 15 g in 1 TUBE (63433-389-00) 15 g 2018-01-01 0000-00-00 No No Current